RESEARCH APPLICATION FORM (SHORT FORM - DIAGNOSTIC)
Medical Radiation Protection Committee
Rev. 1/22/14
This form may be used only for projects involving routine diagnostic x-rays of the extremities, head, neck, teeth, chest, or DEXA bone
density scans. This form may not be used if the project includes: research-related procedures with an effective dose equivalent
greater than 100 mrem, or radiation exposure to minors or pregnant women; radiation procedures performed outside UIHC, UI
College of Dentistry, or VAMC facilities. See accompanying sheet for more information. Submit to the Human Subjects Office (56564) with your IRB submission. For more information, contact the Radiation Safety Officer at (5-8517).
Principal Investigator:
Phone/Pager #:
Fax #:
Email:
Contact person:
Phone/Pager #:
Supervising faculty member (if different from above):
Co-investigators:
Degree:
Department:
Campus address:
Email:
Fax #:
Project title:
1. Brief description and justification of radiation procedures for research. Include number and types of procedures.
2. Provide the effective dose equivalent from each procedure. (See data on accompanying information sheet).
Total effective dose equivalent
3. Department in which radiographic procedures will be done.
Subjects will be recruited from the Veterans Administration Medical Center (If true, submit a VA Consent Document.)
4. Will female subjects of child-bearing potential be recruited as subjects?
Y
or N
If yes, the instructions listed in Item 4 of the accompanying Instructions and Information sheet must be followed, and the
Consent Document must contain the applicable IRB approved Radiation Exposure in Women Capable of Becoming Pregnant
heading and paragraph specified in the Item 4 instructions.
5. Will any non-Radiology personnel be occupationally exposed to ionizing radiation? Y
UI/UIHC identification number.
or N
If yes, list their names and
6. The following radiation risk statement must be included in the Consent Document with the correct value inserted into the sentence
below. (See attached Instructions & Information) “The maximum amount of radiation from the research-related radiation
procedures in this study is about equal to the average environmental radiation everyone experiences in
(days or months).
Although there are no proven harmful effects from this amount of radiation, long term effects on your health such as cancer cannot
be ruled out with certainty. This dose estimate takes into account only the exposure to research procedures in this project. If you
have participated in other research studies involving radiation exposure, you should be aware that the risk of effects from
radiation is believed to increase with each exposure you receive (including studies performed as part of your medical care).”
Responsible Investigators: All projects must be under the control of a tenure track faculty or clinical track faculty member of this
University. I understand that I am responsible for this project and for assuring compliance with all applicable University of Iowa, State
and Federal policies and regulations.
_________________________________________
Signature of Principal Investigator
_________________________________________
Signature of Tenure Track/Clinical Track Faculty Member
(if different from above)
____________________
date
____________________
date
SHORT FORM RESEARCH MRPC APPLICATION
Instructions and Information
*** Do not submit this page with your application. ***
This form may be used only for projects involving routine diagnostic x-rays of the extremities, head, neck, teeth, chest, or DEXA bone
density scans. This form may not be used if the project includes: research-related procedures with an effective dose equivalent
greater than 100 mrem, or radiation exposure to minors or pregnant women; radiation procedures performed outside UIHC, UI
College of Dentistry, or VAMC facilities. Submit to the Human Subjects Office (5-6564) with your IRB submission. For additional
information, contact the Radiation Safety Officer at (5-8517).
Instructions for each item, number 1 through 6, on the short form application are given below.
1. List the number and type of research radiographic procedures. Give a brief rationale for each procedure. (Do not include procedures
that would be performed for clinical reasons even if the subjects did not participate in this project.)
2. For each radiographic procedure listed in item #1, give the effective dose equivalent. Approximate values provided in the table
below may be used. For procedures not listed, dose estimates may be obtained from the Medical Radiation Protection Committee’s
medical physics consultant at mrpc-consultant@uiowa.edu .
Dosimetry estimates for common adult procedures
chest (two films)
hands or wrists (per film)
arm or elbow (per film)
feet or ankles (per film)
tibia or knee (per film)
dental periapical or bitewing (per film)
skull (per film)
cervical spine (per film)
DEXA bone density scan
Mammogram (2 films both breasts)
Effective dose equivalent
(mrem)
6
1
1
1
1
0.2
20
3
1
50
3. Indicate whether the procedures will be done in Radiology facilities or in another department.
4. Female subjects who are pregnant are to be excluded from research studies involving ionizing radiation.
 If the estimated fetal exposure from the research-related radiation procedure is greater than 1 mrem:
Women of childbearing potential may receive radiation for research purposes only if (a) a pregnancy test performed within 24
hours prior to the procedure is negative and (b) the subject confirms that there is no possibility that she became pregnant in the
previous 14 days (since standard pregnancy testing cannot reliably exclude pregnancy within 14 days after conception). A
pregnancy test is required prior to each research-related exposure to radiation, and the results must be available before the
radiation procedure is performed. The following heading and pregnancy testing paragraph must be included in the Consent
Document:
Radiation Exposure in Women Capable of Becoming Pregnant
You may not participate in this study if you are pregnant. If you are capable of becoming pregnant, we will perform a pregnancy
test before each exposure to research-related radiation. You must tell us if you may have become pregnant within the previous 14
days because the pregnancy test is unreliable during that time.
 Or if the estimated fetal exposure from the research-related radiation procedure is less than 1 mrem:
Pregnancy testing is not required where fetal exposures are expected to be below 1 mrem. Radiation procedures that would be
expected to yield fetal doses less than 1 mrem include dental x-rays, x-rays of the extremities (excluding legs above the knee),
chest x-rays, and peripheral DEXA bone mineral scans. It is required that the subject be asked whether she has reason to believe
she might be pregnant. Documentation must be kept to demonstrate the question was asked along with the subject’s response. If
the subject believes she might be pregnant, a pregnancy test must be administered. If the pregnancy test is positive, the subject is
no longer eligible to participate in the research project. The following heading and pregnancy testing paragraph must be included
in the Consent Document:
Radiation Exposure in Women Capable of Becoming Pregnant (fetal radiation dose < 1 mrem)
You may not participate in this study if you are pregnant. If you believe you could be pregnant, we will perform a pregnancy test
before each exposure to research-related radiation. You must tell us if you may have become pregnant within the previous 14 days
because the pregnancy test is unreliable during that time.
The MRPC requires the investigator to provide documentation indicating that the total fetal dose for the radiation studies
the subject will undergo does not exceed 1 mrem. It also requires the investigator provide abdominal shielding for all
female participants.
Note: The MRPC policy exception does NOT supersede IRB or study sponsor requirements for pregnancy testing of
subjects.
5. All non-Radiology personnel exposed to radiation during a research project must have annual radiation safety training. The
Environmental Health & Safety Office (formerly HPO) will check to ensure that all individuals listed in this section have completed
training before they may be exposed.
6. All projects must have a radiation risk statement in the Consent Document. For the sake of simplicity, all investigators are required
to complete and use the risk statement given in #6. To complete the risk statement, insert in the box the number of days (weeks or
months) based on the following: 1.2 days/mrem x total effective dose equivalent in mrem (from table above).
As an example, if the total effective dose equivalent from all radiological procedures is 23 mrem, then the risk associated with the
procedure(s) is equal to (1.2 days/mrem) x (23 mrem) = 30 days or 1 month of environmental radiation exposure. Insert the
simplest time in the box provided for item number 6 of the short form, i.e. 60 days = 2 months, and so on.
For your reference, the average exposure to the general public in the United States from environmental radiation is equal to 300
mrem/year.
If your project involves a situation not covered by these guidelines or for additional information, contact the Radiation Safety Officer
at 335-8517.
Short Form MRPC App. Rev. 10/19/11
Human Use MRPC FAQs